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Recruiting NCT07404774

Hemorrhoid Suture Mucopexy Combined With Laser Hemorrhoidoplasty

— Observational Haemorrhoid Haemorrhoidal Bleeding Anorectal Surgeries Anorectal Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laser Haemorrhoidoplasty and Suture Mucopexy.
Who it may be relevant to
Registry conditions: Haemorrhoid, Haemorrhoidal Bleeding, Anorectal Surgeries, Anorectal Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Evaluation of Hemorrhoid Suture Mucopexy (SM) Combined With Laser Hemorrhoidoplasty (LHP) for Symptomatic Hemorrhoidal Disease: A Cohort Study

Overview

This prospective cohort study evaluates whether combining "suture mucopexy" (a simple stitch-based lift of prolapsed tissue) with Laser Hemorrhoidoplasty (LHP) can effectively relieve pain, bleeding and prolapse in adults with moderate-to-severe hemorrhoids (Grades II-IV). Participants will undergo the combined, non-Doppler-guided procedure and be followed for one year. The primary question is how long patients need post-operative pain medication and if they first experience complete symptom relief; secondary questions examine quality-of-life, safety (bleeding, urinary retention, stenosis) and the rate of hemorrhoid recurrence/re-operation.

Detailed description

Laser Hemorrhoidoplasty (LHP) offers a minimally invasive option for symptomatic hemorrhoids, yet in advanced disease (Goligher III/IV) recurrence rates of 20-35 % have been reported because residual mucosal prolapse persists. Adding a suture-based mucopexy (SM) eliminates the prolapse and ligates feeding vessels without the need for Doppler guidance, thereby potentially reducing recurrence while preserving the low-pain advantage of LHP. Preliminary experience with 50 patients at this centre demonstrated feasibility, low early complication rates, and promising symptom control, justifying a formal prospective evaluation.

The present study is a single-center, prospective observational cohort enrolling consecutive eligible adults over a 24-month accrual period. All participants receive the same combined LHP + SM technique; no comparator arm is planned. Follow-up visits occur at postoperative week 6, month 6 and month 12.

Interventions

  • Procedure Laser Haemorrhoidoplasty and Suture Mucopexy
    The procedure combines laser ablation (LHP) with suture mucopexy (SM) performed without Doppler guidance. Suture Mucopexy (SM): Using a slotted proctoscope, continuous suture mucopexy (plication) is performed at standardized anatomical positions (typically 4, 7, 11 o'clock) to lift the prolapse and ligate feeding vessels. Sutures are placed approximately 2-4 cm proximal to the dentate line. Laser Hemorrhoidoplasty (LHP): A 1470nm diode laser fiber is inserted into the hemorrhoidal cushion. Ene

Primary outcome measures

  • Duration of analgesia [Time frame: perioperatively]
  • Primary Symptom Relief [Time frame: perioperatively]
Secondary outcome measures (4)
  • Nyström Hemorrhoid Severity Score (HSS) [Time frame: 12 months]
  • Morbidity [Time frame: 3 months]
  • Complications [Time frame: 12 months]
  • Reoperation Rate [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Adults (>18 years).
  • Symptomatic Hemorrhoidal Disease (Goligher Grades II, III, IV).
  • Patients with or without recurrent disease after prior procedures (e.g., RBL, infrared coagulation, Milligan-Morgan, etc).

Exclusion criteria

  • Acutely thrombosed hemorrhoids.
  • Concomitant anal fistula or abscess requiring separate surgical management.
  • IBD (Crohn's/Ulcerative Colitis) with active rectal involvement.
  • Previous Stapled Haemorrhoidopexy (SH/Longo).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Greece · 1 center
  • Ippokrateio Hospital — Athens

Identifiers

NCT: NCT07404774 · 100/22-12-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗